Scientist, Flow Cytometry - Orcabiosystems : Job Details

Join to apply for the Scientist, Flow Cytometry role at Orca Bio

Join to apply for the Scientist, Flow Cytometry role at Orca Bio

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The flow cytometry scientist will join the CMC team and work cross-functionally with several departments (R&D, Process Development, Analytical Development, Quality Control) as the subject matter expert for the development, qualification and maintenance of the flow cytometry-based assays for Orca Bio's cell therapy-based drug products. This role includes development and execution of lab-based studies and hands-on training of scientists in specific methods, troubleshooting methods, assuring methods developed by are robust and ready. Additionally, the role will be involved in overseeing method transfers into the GMP operations. The flow cytometry scientist will participate in writing documentation for regulatory filings. The candidate must be independent, project-oriented, timeline-driven, and able to efficiently work across multiple departments. The position is focused on enhancing the use of flow cytometry assays and assuring flow assay development, transfer to QC, and validation results in robust GMP capable flow assays.Responsibilities

• Design and execute lab-based studies to develop and enhance flow-based assays for cell therapy products
• Support method development, qualification and validation studies for flow cytometry assays
• Manage transfer activities to ensure method readiness for manufacturing and product release
• Teach and train other scientists in flow cytometry and other cell-based assays
• Author and review laboratory specific processes and procedures as well as technical documents such as methods, qualification/validation protocols, reports, and CMC sections for regulatory filings
• Participate in the investigation and resolution of Out of Specification investigations

Qualifications

• BS Degree in immunology, cellular and molecular biology, biological sciences, or a closely related field; PhD preferred
• Experience in developing flow cytometry assays; minimum 5 years specifically in flow cytometry
• Advanced educational background can substitute for industry experience
• Knowledge of GMP regulations is a plus
• Excellent attention to detail, organizational skills, and ability to multi-task in a dynamic environment

Who We AreWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo.We maintain a start-up culture of camaraderie and leadership by example, regardless of title.We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.Notice to staffing firmsOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology
• IndustriesPharmaceutical Manufacturing

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